Catalog Number 254500138 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Investigation summary: examination of the returned device confirms the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that the: trial extractor tips are chipped off and needs to be replaced.All pieces were retrieved.Attune femoral impactor has a piece broken off and needs to be replaced.All pieces were retrieved.Attune tibial impactor is cracked and needs to be replaced.All pieces were retrieved.Spacer block handle is broken at connection peg and needs to be replaced.The peg and the spring are damaged.All pieces were retrieved.
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Manufacturer Narrative
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Product complaint # = > pc-(b)(4).Investigation summary = > examination of the returned device confirms the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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